Acute Effectiveness Research Articles

J021014 柔道における急性硬膜下血腫発生評価指標の比較と頭部保護具の効果

J021014 柔道における急性硬膜下血腫発生評価指標の比較と頭部保護具の効果

Left main coronary artery bifurcation angioplasty and stenting after aortic valve replacement: a case report

A 43-year-old young lady had closed mitral valvotomy (CMV) in 1994 and aortic valve replacement (AVR) in June 2007. Shortly thereafter, she presented with unstable angina in October 2007 with on-going pain and haemodynamic instability. Coronary angiogram showed tight left main bifurcation stenosis in a left dominant system. Having had open heart surgery (AVR) recently, and being on oral anticoagulation, with on-going ischaemia and unstable haemodynamics, percutaneous coronary intervention (PCI) was considered the most suitable option. She underwent successful PCI with two drug-eluting stents (T-stenting) to left main bifurcation through transradial approach and intra-aortic balloon support. Clinically she remained symptom free and coronary angiogram after 5 months and 15 months of follow-up showed patent stents. This case demonstrates the acute effectiveness of PCI for the treatment of critical left main disease following open heart surgery in patients who are not appropriate surgical candidates.

The acute and long‐term effectiveness of amisulpride in patients with schizophrenia: results of a 12‐month open‐label prospective follow‐up study

To compare the effectiveness of amisulpride in acute (up to 8 weeks) and maintenance (week 8 to 12 months) phases of a 12-month course of treatment in a heterogeneous group of patients with schizophrenia. We conducted a 12-month, open-label clinical trial with flexible doses of amisulpride among 129 Korean patients with schizophrenia. The Positive and Negative Symptom Scale (PANSS) and several other scales measuring efficacy and tolerability were analyzed during the acute and maintenance phases. The completion rates were 78.3% by week 8 and 55.8% by month 12. Total PANSS scores and scores on the negative-symptom and general-symptom subscales improved significantly during both acute and maintenance periods, but scores on the positive-symptom subscale improved only during the acute phase. Improvement during both treatment phases was significant in all other scales except for the Drug Attitude Inventory. The negative-symptom and mixed-symptom groups showed significant improvement in the PANSS negative subscale, the Clinical Global Impression scale, and the Global Assessment of Functioning during the maintenance period. Hyperprolactinemia and related events were commonly reported. This study demonstrated the significant effectiveness and a good safety profile of amisulpride for treating acute and 12-month phases of schizophrenia under natural conditions.

Abstract A52: A phase III skin cancer chemoprevention study of DFMO in subjects with a history of non-melanoma skin cancer (NMSC): Follow-up of NMSC events greater than 5 years post-study participation

Abstract The most commonly diagnosed malignancy in the United States is non-melanoma skin cancer (NMSC) with > 2 million new cases of basal cell carcinoma (BCC) and squamous cell carcinoma (SCC) predicted for 2010. The economic burden and increasing incidence in younger populations, especially women, reinforces the value of skin cancer prevention. Health education and prior attempts at skin cancer chemoprevention have had limited success. A strong link between epithelial carcinogenesis and elevated polyamines, together with a series of phase I and II trials, led to a NCI-sponsored phase III double-blind, placebo-controlled skin cancer chemoprevention trial of α-difluoromethylornithine (DFMO) (500 mg/m2/day) for 4–5 years in 291 subjects with a history of NMSC. Subjects receiving DFMO developed significantly fewer BCC s than placebo subjects with an event rate of 0.28 BCC/person/year versus 0.40 BCC/person/year, (P = 0.03; Total BCCs: DFMO 163, placebo 243). DFMO appeared to have minimal effects on SCC incidence (DFMO 0.15 SCC/person/year, placebo 0.19, p=0.56; Total SCCs: DFMO 95, placebo 115). Subjects tolerated DFMO well, and the only significant observed toxicity was increased audiometric hearing loss. A key issue in the clinical viability of a chemoprevention agent after acute effectiveness and/or tolerance is the latent effectiveness and/or toxicity of the agent. Such effects attributable to DFMO have not been assessed. Earlier chemoprevention research has observed positive and negative latent effects with chemopreventive agents. Use of tamoxifen (5 years) for breast cancer prevention provided continued or greater protection for up to 10 years after drug stoppage. On the contrary, early work with retinoids in oral cancer prevention implied a rebound effect with subjects developing more neoplasms upon discontinuation. Also, the recent linkage between isotretinoin and inflammatory bowel disease is a concerning example of toxicity experienced years after use of a chronically administered agent. The continued interest in DFMO as a chemopreventive agent provided cause to update the clinical data and overall health status of the 291 subjects from the phase III skin cancer prevention study of DFMO to understand the sustainability of the observed DFMO effects. After institutional review board approval, we reviewed medical records of 243 subjects who received care at UW Health. Individual records were manually reviewed, and a pending comparative review of data mining by Natural Language Processing will also be completed. Both reviews focused on the skin cancer events by histology, other neoplasia (invasive and non-invasive), significant other diagnoses, and survival. The rate of skin cancer recurrence from end of study drug to the time of last medical contact (the primary endpoint) was compared between subjects randomized to DFMO or placebo using a two-sample test for primary analysis. As a secondary analysis, the rate of skin cancer recurrence from randomization to the time of last medical contact was also compared. In an exploratory analysis, the primary endpoint was analyzed using Poisson regression models to account for the baseline patient/disease characteristics at the time of randomization such as sex and age of patients and pre-study skin cancer history. Data from the 243 subjects totaling over 2,300 person years is undergoing further validation and preliminary data analysis, and will be available shortly. Citation Information: Cancer Prev Res 2011;4(10 Suppl):A52.

Long-Term Outcomes with Medications for Attention-Deficit Hyperactivity Disorder

Attention-deficit hyperactivity disorder (ADHD), a common neurobehavioural disorder characterized by inattention, hyperactivity and impulsivity, is a chronic disorder and often persists into adulthood. CNS stimulants have been the most well known treatment for ADHD for several decades due to their high effectiveness, good safety profiles and relatively minor adverse effects. Non-stimulant agents, including atomoxetine, extended-release guanfacine and extended-release clonidine (US FDA approved), and several non-FDA-approved agents, such as bupropion and tricyclic antidepressants (TCAs), were recently proven to be effective alternatives to the stimulants in several open-label and placebo-controlled trials. However, most medication trials for ADHD have been short term and thus have not provided information on the long-term outcomes of ADHD treatment. Since the medical treatment of many children with ADHD, especially those with more severe symptoms or co-morbid disorders, has to be continued for several years, recent studies have shifted their focus from the acute effectiveness of stimulants or non-stimulant drugs to the long-term outcomes of medications for ADHD. Evidence has shown that stimulants, along with the non-stimulants atomoxetine and extended-release guanfacine, are continuously effective for 24-month treatment periods with few and tolerable adverse effects.

Evaluation of psychiatric interventions in an observational study: issues in design and analysis

Characteristics of randomized controlled clinical trials (RCTs) and observational studies of psychiatric intervention effectiveness are contrasted. Randomization drives treatment assignment in an RCT, whereas clinician and patient selection determine treatment in an observational study. Strengths and weaknesses of randomized and observational designs are considered. The propensity adjustment, a statistical approach that allows for intervention evaluation in a nonrandomized observational study, is described here. The plausibility of propensity adjustment assumptions must be carefully evaluated. This data analytic strategy is illustrated with the longitudinal observational data from the National Institute of Mental Health Collaborative Depression Study. Evaluations presented here examine acute and maintenance antidepressant effectiveness and demonstrate effectiveness of the higher categorical doses.

Improvements in both psychosis and motor signs in Parkinson's disease, and changes in regional cerebral blood flow after electroconvulsive therapy

Psychotic symptoms in Parkinson's disease (PD) are relatively common and, in addition to creating a disturbance in patients' daily lives, have consistently been shown to be associated with poor outcome. The use of anti-PD medications has been the most widely identified risk factor for PD psychosis (PDP). However, the pathophysiology of PDP remains unclear. Although the efficacy of electroconvulsive therapy (ECT) for PD had been pointed out, only one study has demonstrated the effectiveness of ECT on both psychotic symptoms and motor symptoms. The aim of this study was to examine the acute effectiveness of ECT on PD and to identify the brain areas associated with PDP. The study was conducted at Juntendo University Hospital in Tokyo. Eight patients with L-DOPA- or dopamine (DA) agonist-induced PDP, who were resistant to quetiapine treatment, were enrolled. Severity of PD was evaluated using the Hoehn and Yahr stage. Psychotic symptoms were evaluated using multiple measures from the Scale for the Assessment of Positive Symptoms (SAPS). Technetium-99m ethyl cysteinate dimer single photon emission computed tomography (99mTc ECD SPECT) was used to assess regional cerebral blood flow (rCBF) before and after a course of ECT. A voxel-by-voxel group analysis was performed using Statistical Parametric Mapping (SPM5). Our study clearly demonstrated that PDP was significantly less severe after ECT than before ECT, as indicated by change in mean SAPS total domain score (t=7.2, P=0.0002). Furthermore, the patients showed significant improvement in Hoehn and Yahr stage after ECT (t=11.7, P<0.0001). A further notable observation was significant increase in rCBF in the right middle frontal gyrus after ECT. We conclude that a course of ECT produced notable improvements not only in PDP but also in the severity of PD. The findings of change in rCBF suggest implications for dysfunction in the middle frontal region for patients with PDP.

A review of the effectiveness of an established residential weight management intervention on short-term health outcomes in overweight and obese youth

Background: The incidence of overweight and obesity in youth is rapidly escalating to epidemic proportions (WHO, 2004). Multi-component interventions have been highlighted as the treatment of choice (NICE, 2006) but the current evidence base is limited and many interventions have not been properly evaluated. The Carnegie International Camp (CIC), an annual, residential, multi-component weight management intervention, has been previously demonstrated to be effective across a range of health outcomes for overweight and obese children and adolescents (Gately et al., 2005). The current study aimed to review the continued effectiveness of the CIC programme through evaluation of the same range of health outcome parameters. Methods: Two hundred and ninety young people (aged 8–18 years) were recruited (UK and internationally) for the 2006–2008 CIC programmes. It was not possible to identify a control group or to obtain random samples due to the specific nature of the intervention. Anthropometric and psychological outcome variables were measured on the first (baseline) and last day of each participants stay, and repeated weekly. Outcome variables measured: weight, height, waist circumference, body composition, blood pressure, aerobic fitness and self esteem. Some participants attended successive CIC programmes; only data from participants’ first programme attendance were included for analysis. To control for study attrition only complete data sets were included in the analysis. Independent t-tests were utilised to identify group differences at baseline between the participant cohort of the current study (2006–2008) and the 1999–2002 participant cohort evaluated by Gately et al. (2005). Repeated measures anova tested for the significance of pre-post intervention changes within and between cohorts. Analysis was conducted using SPSS v16.0 with P < 0.05 accepted as significant. The CIC programme and all subsequent analyses were granted full ethical approval by NHS Leeds West Teaching Hospital Research Ethics Committee. Results: One hundred and ninety-three complete data sets were obtained (2006–2008); significant improvements (P < 0.05) were attained across all outcome variables in this cohort. Comparison with Gately et al. (2005) findings revealed similar changes were achieved in both studies: Variable 1999–2002 cohort (Gately et al., 2005) 2006–2008 cohort Baseline (SD) Change Baseline (SD) Change Height (cm) 162.76 (9.7) +0.29 163.21 (9.7) +0.32 Weight (kg) 89.89 (24.4) -6.06 91.83 (23.8) -5.56 BMI (kg m-2) 33.48 (6.2) -2.36 34.10 (6.8) -2.19 BMI SDS 3.03 (0.6) -0.29 3.06 (0.6) -0.27 Body fat % 40.77 (6.1) -2.63 43.25 (7.7) -4.01 Fat mass (kg) 37.19 (14.5) -4.63 40.32 (16.8) -5.98 Waist (cm) 96.62 (12.7) -6.29 95.27 (14.5) -5.47 BP systolic (mmHg) 118.97 (7.7) -6.88 118.53 (15.8) -3.23 BP diastolic (mmHg) 70.78 (6.4) -4.97 75.20 (13.3) -7.92 Self esteem 2.56 (0.6) +0.21 2.30 (0.6) +0.22 Discussion: Similarimprovements across outcome variables were achieved in both cohorts evaluated, demonstrating the continued acute efficacy of the CIC. Direct comparison between different interventions is difficult due to programme heterogeneity, but repetition of existing studies provides benefits such as increased sample size, reduces variation of results and increases confidence in the effects of the experimental factor being examined. Conclusion: The CIC continues to demonstrate an acute effectiveness in producing positive outcomes across a range of physiological and psychological variables associated with overweight and obesity in young people. Discussion: Similarimprovements across outcome variables were achieved in both cohorts evaluated, demonstrating the continued acute efficacy of the CIC. Direct comparison between different interventions is difficult due to programme heterogeneity, but repetition of existing studies provides benefits such as increased sample size, reduces variation of results and increases confidence in the effects of the experimental factor being examined. Conclusion: The CIC continues to demonstrate an acute effectiveness in producing positive outcomes across a range of physiological and psychological variables associated with overweight and obesity in young people.

Major Symptom Score Utility Index for Patients with Acute Rhinosinusitis

Evaluation of acute rhinosinusitis treatment effectiveness is based on patient-reported relief of symptoms. This study was designed to develop a multiattribute utility scoring algorithm for the Major Symptom Score (MSS) and secondarily to evaluate the psychometric characteristics (i.e., validity and responsiveness) of the MSS Utility Index (MSSUI). Adult patients with acute rhinosinusitis were recruited for this longitudinal observational study through primary care and specialist physician offices. One hundred ninety patients participated in a preference elicitation exercise for MSS health states. Resulting preference data were used to generate a utility scoring algorithm for the MSS. Participants completed the MSS and 20-Question Sino-Nasal Outcome Test (SNOT-20) at baseline and completed the MSS twice daily for 15 days via daily diary. On days 7 and 15, participants completed the MSS, SNOT-20, and Overall Treatment Effect scale and were evaluated by physicians via the Physician Global Improvement Scale (PGIS). At baseline, the mean ± SD. MSSUI score was 0.51 ± 0.17 and was negatively correlated with SNOT-20 scores (r = -0.58; p < 0.001). Days 2-8 average MSSUI scores were negatively correlated with day 7 SNOT-20 (r = -0.46; p < 0.001) and PGIS (r = -0.22; p < 0.001) scores; whereas days 9-15 average MSSUI scores were inversely related to day 15 SNOT-20 (r = -0.40; p < 0.001) and PGIS (r = -0.32, p < 0.001) scores. Mean MSSUI scores improved from baseline with effect sizes at days 7 and 15 of 0.82 and 1.20, respectively. The MSSUI represents an acceptable and psychometrically sound patient-reported end point for clinical trials comparing treatments for acute rhinosinusitis.

The Acute Effectiveness and Safety of the Constant-Flow, Pressure-Volume Curve to Improve Hypoxemia in Acute Lung Injury

To investigate the effectiveness of the constant-flow, pressure-volume curve (PVC) to prescribe positive end-expiratory pressure (PEEP) in acute lung injury (ALI) and risk of cardiopulmonary deterioration during the PVC process. A retrospective, cohort study. A surgical intensive care unit (ICU) of a tertiary, university hospital. Fifty consecutive ventilated patients diagnosed with ALI undergoing the PVC maneuver from 1999 to 2003. Titration of PEEP based on the lower inflection point of the constant-flow, pressure-volume curve. Patients were divided into 2 groups based on PVC-guided PEEP changes of <3 cm H2O (PVC-NC or "no change") or ≥3 cm H2O (PVC-CHG or "change") from the initial empiric prescription. There was a greater increase in partial pressure of arterial oxygen (PaO2)/fractional concentration of inspired oxygen (FiO2) in the PVC-CHG group, with a mean change of 80 ± 50 (95% confidence interval [CI] 61, 98) versus 42 ± 54 (95% CI 17, 67) in the PVC-NC group. Eighty-two percent of patients (41/50) showed an increase in ratio of partial pressure of arterial oxygen to fraction of inspired oxygen (PaO2/FiO2) by 20% within 6 to 24 hours after the PVC test-greater in the PVC-CHG group (OR 1.44, 95% CI 1.02, 2.01). Thirteen percent (4/30) within the PVC-CHG group and none within the PVC-NC group (0/20) required a 25% increase in vasoactive infusion rates (P = .089) in relation to the procedure. Univariate logistic regression showed that PVC-CHG was significantly associated with a 20% change in PaO2/FiO2 (OR 7.54, 95% CI 1.37, 41.41). Multivariate logistic modeling showed that PVC-guided PEEP changes of ≥3 cm H2O, age ≤65 years, and pre-PVC FiO2 ≥ .85 were significantly associated with a 20% increase in PaO2/FiO2 (receiver operator area under the curve = .86). In the setting of acute lung injury, use of the constant-flow, pressure-volume curve to prescribe PEEP appears associated with improvement in oxygenation with limited risk of acute, process-related, cardiopulmonary deterioration.

Ginseng for Reducing the Blood Pressure in Patients with Hypertension: A Systematic Review and Meta-Analysis

Ginseng is one of the most-widely used herbal remedies. This systematic review evaluates the current evidence for its use in the reducing blood pressure (BP) in patients with hypertension. Systematic searches of 12 electronic databases were conducted without language restrictions. All randomized clinical trials (RCTs) of ginseng as a treatment for hypertension were candidates for inclusion. Methodological quality was assessed using the Cochrane risk of bias. Five RCTs met the inclusion criteria. The risk of bias was low in most of the trials. Four of the included RCTs compared the effectiveness of ginseng to placebo. The meta-analysis of these data failed to show a statistically significant acute effect on systolic BP (SBP) or diastolic BP (DBP). However, subgroup analyses showed beneficial effects of Korean red ginseng (KRG) on both SBP (n=54, mean difference [MD], -6.52; 95% confidence interval [CI], -9.99 to -3.04; p=0.0002) and DBP (n=54, MD, -5.21; 95% CI, -7.90 to -2.51; p=0.0001). Two RCTs tested the long-term effects of ginseng for BP for 24hours. One of these trials failed to show any benefits of KRG compared to no treatment, and the other failed to show superior effects of North American ginseng compared to placebo. Adverse events with ginseng were none in one trial or not assessed. Collectively, these RCTs provide limited evidence for the acute effectiveness of KRG in the treatment of high BP. The total number of RCTs included in the analysis and the total sample size were insufficient to draw definitive conclusions. More rigorous studies are warranted.

Findings From the Treatment for Adolescents with Depression Study (TADS): What Have We Learned? What Do We Need to Know?

This introduction to the special section on findings from the Treatment for Adolescents with Depression Study provides a review of the rationale for the study, its design, and principal findings to date. Findings with regard to acute effectiveness of alternative treatments, relapse, recurrence, maintenance of gains, and the effects of treatment on suicidal ideations and suicidal behavior are reviewed. We conclude with a brief discussion of unresolved clinical issues, including treatment resistance, management of partial response, moderators and predictors of long-term response, and mediators of clinical change. The articles of the special section address a range of issues including relations between cognitive factors associated with depression, relations between maladaptive beliefs and treatment response, cognitive mediators of therapeutic improvement, relations between family conflict and treatment response, and the economic costs of adolescent depression.

Repetitive transcranial magnetic stimulation treats postpartum depression

Postpartum depression (PPD) is a prevalent illness, affecting 10-15% of new mothers. PPD is the most common complication of childbirth and is a significant public health concern. It is known to adversely impact maternal-infant bonding, childrearing practices, and can lead to suicide and infanticide. The current treatment approaches to PPD are suboptimal. Many mothers are reluctant to take medication because of concerns about side effects or exposure of their newborn infant through breastfeeding. The specific aims of this study were to (1) examine acute treatment effectiveness, (2) examine response durability, and (3) assess an effect of repetitive transcranial magnetic stimulation (rTMS) on maternal bonding. Nine antidepressant-free women with PPD were given 20 rTMS treatments over 4 weeks (10Hz, 120% motor threshold, left dorsolateral prefrontal cortex). Multiple characteristics were assessed at baseline and throughout treatment. Duration of effect was assessed at 30 days, 3 months and 6 months posttreatment. Friedman's tests were conducted on Hamilton Rating Scale for Depression-24 item (HRSD-24), Edinburgh Postnatal Depression Scale (EPDS), Inventory of Depressive Symptomatology-Self-Report (IDS-SR) and Clinical Global Impressions-Severity (CGI-S) scores to compare performances at four time points (baseline, end of Week 2, end of Week 4, and 180-day follow-up). Overall, these results revealed a significant reduction in depressive symptoms by the end of Week 2 of treatment. Analyses yielded a medium effect size (r=0.68) on the primary outcome variable (HRSD-24). Of note, all nine patients remained in treatment for the complete 4 weeks, did not miss any treatment sessions and eight participants achieved remission of symptoms, defined as a HRSD<10 and a CGI-S=1. Analysis of follow-up data indicated robustness of the rTMS treatment over time. At 6-month follow-up, of the eight women that remitted, seven remained in remission without further psychiatric intervention, including the addition of medication and one was lost to follow-up. Results also indicated a significant improvement in bonding. Our results demonstrate promising results for the use of rTMS in the treatment of PPD. Further randomized, sham-controlled studies need to be completed.

Effects Of Fenugreek, Cinnamon, &amp; Curcumin On Post Workout Inflammatory Response.

It has been documented that strenuous exercise suppresses cellular immunity leading to increased susceptibility to infections and delayed recovery. As mediators of these phenomena, cytokines released into the circulation have been a recent focus of attention. PURPOSE: To assess the acute effectiveness of fenugreek, cinnamon, & curcumin on blunting inflammatory markers after muscle damage. METHODS: Twenty healthy non-resistance trained male and female subjects were equally divided by gender and assigned to ingested either a proprietary blend of fenugreek, cinnamon, & curcumin (N = 10, 21 ± 2.8 yrs, 174 ± 10 in, 77 ± 20 kg) or placebo (N = 10, 20 ± 1.9 yrs 175 ± 14in, 89 ± 20 kg). Subjects ingested 450 mg of either active supplement (400mg fenugreek, 25mg cinnamon, 25mg curcumin) or 450 mg of placebo for 14 days prior to the damage bout. Subjects were instructed to warm-up briefly and subsequently perform 24 sets of 10 eccentric knee extensor repetitions with one leg at 30°/s on an isokinetic device. Subjects had their blood drawn at baseline, immediately post, 1hr, 3hr, and 24hr post damage. Serum samples were analyzed for IL 1b, IL1ra, IL6, TNFa and CRP levels using a multiplex bead based assay. Data were analyzed by a two-way ANOVA with repeated measures (p<0.05). RESULTS: Significant (p<0.05) main effects for time were observed for the inflammatory markers IL 1b, IL1ra, & IL6, although there were no significant (p>0.05) interactions. However, a significant trend for interaction was observed for IL 6 (p=0.06) & IL1 ra (p = 0.09). Post hoc analysis revealed a significant difference immediately post damage in IL 1ra where active group was significantly lower than the placebo group (p<0.05) and a significant difference at 1hr & 3hr post damage IL6 where active was significantly lower (p<0.05) than placebo. CONCLUSION: These results indicate that the protocol used induced significant (p<0.05) systemic inflammation. The experimental proprietary blend showed some positive anti-inflammatory effects as illustrated by a significantly (p<0.05) lower inflammatory response in IL1ra and IL 6 by 3hr post damage. It is concluded that fenugreek, cinnamon, and curcumin have potential anti-inflammatory properties and that they significantly reduced the onset of inflammation in response to muscle damage. This study was funded by Indus Biotech.

Publication Bias and the Efficacy of Antidepressants

Publication Bias and the Efficacy of Antidepressants

Ketanserin, a 5-HT 2 receptor antagonist, decreases nicotine self-administration in rats

Nicotine intake constitutes a principal mechanism for tobacco addiction. In addition to primary effects on nicotinic acetylcholine receptors, nicotine has cascading effects, which may also underlie its neurobehavioral actions. Nicotine induces serotonin (5-HT) release, which has not classically been thought to be involved in tobacco addiction as dopamine has. However, addiction can be characterized more as a disorder of compulsion than a disorder of enjoyment. 5-HT mechanisms play key roles in compulsive disorders. Nicotine-induced 5-HT release may be a key to tobacco addiction. Ketanserin, a 5-HT2a and 5-HT2c receptor antagonist, significantly attenuates nicotine effects on attention and memory. These studies were conducted to determine if ketanserin would reduce nicotine self-administration in rats. Male Sprague–Dawley rats ( N = 12) were given initial food pellet training and then 10 sessions of nicotine self-administration training (0.03 mg/kg/infusion, i.v.). Then the rats were administered ketanserin (1 or 2 mg/kg, s.c.) or the saline vehicle. Ketanserin (2 mg/kg) significantly decreased nicotine self-administration. This did not seem to be due to sedative or amnestic effects of ketanserin. In a second study, the effects of repeated administration of 2 mg/kg ketanserin ( N = 11) vs. saline injections ( N = 10) were examined. In the initial phase, the acute effectiveness of ketanserin in significantly reducing nicotine self-administration was replicated. The effect became attenuated during the following several sessions, but the significant effect became re-established during the final phases of this two-week study. 5-HT mechanisms play critical roles in the maintenance of nicotine self-administration. Better understanding of those roles may help lead to new 5-HT-based treatments for tobacco addiction.

Association of body rolling, leg rolling, and rhythmic feet movements in a young adult: A video‐polysomnographic study performed before and after one night of clonazepam

We report clinical and polysomnographic data of a young adult affected by several forms of rhythmic movement disorder (RMD), present in the same night, including a new kind of it, known as rhythmic feet movements. The patient was monitored by means of three consecutive video-polysomnographic recordings, the first two performed to confirm the presence of the sleep disorder and the last one to observe the acute effectiveness of clonazepam on rhythmic movements. We discuss the characteristics of the RMD and the response to the first administration of pharmacological treatment, observed in our patient.

Real-world use of quetiapine in early psychosis: An acute inpatient and community follow-up effectiveness study

Objective. To evaluate the use of quetiapine in first episode psychosis in adolescents and adults in a 26-week open-label trial. Methods. Consenting patients were recruited from consecutive acute psychiatric admissions. Quetiapine was increased stepwise to 750 mg. Baseline, 2, 4, 12, 16, 20 and 26 week measurement included: BPRS, PANSS, CGI, and indices of tolerability and safety. Change was assessed using repeated measures ANOVA. Results. Of 73 first admission patients with psychosis, 15 entered the study. Loss of otherwise eligible patients was mainly related to prospective consent, which appeared to cause selection bias. All 15 patients were retained for 4-week Intention-to-Treat Analysis; nine completed the 26-week protocol (Completers Analysis). Non-completers dropped out shortly after 4 weeks. In the ITT Analysis, there was significant improvement on BPRS Total (P<0.01), PANSS Positive (P<0.05), and CGI (P<0.01) scores. No change in the 2-week BPRS Total score predicted subsequent non-response to quetiapine. In the Completers Analysis, onset of significant PANSS Negative score reduction did not occur until week 12. By 26 weeks all efficacy measures had substantially improved; and substance abuse was markedly less prevalent (P=0.02). Adverse events included postural hypotension, drowsiness, and significant weight gain (P=0.001). Conclusions: This uncontrolled trial suggests quetiapine is an effective first-line treatment in young early psychosis patients. Prospective consent is a major barrier to evaluating acute care for psychotic disorder.

Internal Iliac Artery Embolization before Endovascular Repair of Aortoiliac Aneurysms with a Nitinol Vascular Occlusion Plug

To evaluate the acute and midterm effectiveness of a novel vascular occlusion device for embolization of the internal iliac artery (IIA) before endovascular repair of aortoiliac aneurysms. Between March 2005 and April 2006, nine men (mean age, 75 years +/- 5; range, 66-83 y) with aortoiliac aneurysms underwent bifurcated endovascular stent-graft procedures. All these patients were referred specifically for embolization. Pre- and perioperatively, eight patients underwent unilateral embolization and one underwent bilateral embolization of the IIA to prevent type II endoleak. Via a contralateral femoral approach with a 6-F or 8-F sheath, the embolization procedure was performed with an Amplatzer Vascular Plug, a self-expandable cylindrical device consisting of a nitinol-based wire mesh. Technical success, clinical outcome, and complications were evaluated. Follow-up at 3, 6, and 12 months was performed with clinical and radiologic examinations. IIA embolization was technically successful in all cases and no procedure-related complications occurred. Imaging at discharge and at 3-, 6-, or 12-month follow-up was accomplished in all nine patients. Control computed tomography and magnetic resonance angiography did not reveal retrograde perfusion of the aneurysmal sac, ie, type II endoleak. Three of nine patients (33.3%) reported symptoms of buttock claudication that did not resolve completely. Clinical symptoms such as bowel ischemia or sexual dysfunction were not observed. The midterm results of this study suggest that preoperative IIA embolization with a nitinol vascular occlusion plug during endovascular treatment of aortoiliac aneurysms is safe and effective.

Transvenous cryo-ablation of the slow pathway for the treatment of atrioventricular nodal re-entrant tachycardia: a single-centre initial experience study

Within the last several years, transvenous cryo-ablation has become an alternative method to perform ablation of the slow-pathway. This study evaluated the acute and long-term safety and effectiveness of atrio-ventricular nodal re-entrant tachycardia (AVNRT) cryo-ablation. The first 69 consecutive patients with AVNRT (60 slow-fast, 4 fast-slow, and 5 slow-slow) who underwent slow-pathway cryo-ablation were included. Mean age was 37 +/- 15, body weight 68 +/- 14 kg, symptom duration 125 +/- 104 months, and number of ineffective antiarrhythmic (AA) drugs 1.8 +/- 1.4. A 7 Fr cryo-catheter (Cryocath(A)) was used, with initially 4-mm-tip and later with 6-mm-tip electrode. Cryo-mapping (n = 7.9 +/- 8.4 per pt) was performed at the temperature of -30 degrees C to test the effect on the target ablation site. Successful cryo-mapping was defined as abolition of nodal conduction jump or AV nodal refractory period prolongation. Cryo-ablation (n = 5.1 +/- 4.9 per pt) was then applied by freezing to -75 degrees C for 4 min in duration if no AV-block occurred. Acute procedural success (defined as AVNRT non-inducibility) after the first cryo-ablation attempt was achieved in 60/69 patients (87%). During cryo-ablation, inadvertent transient AV-block was encountered in 14 patients (five I AV-block and nine II-III AV-block). A mid-septal target site was the only variable correlated with inadvertent AV-block occurrence during cryo-ablation (P < 0.02). Long-term clinical success after cryo-ablation was globally achieved in 56/66 (85%) with a mean follow-up of 18 +/- 9 months (3 pts dropped-out). After the first procedure, 41/66 (62%) had no relapse, eight had a dramatic reduction in AVNRT duration-frequency and considered themselves cured, and five needed previously ineffective AA (with no relapse in three, drastic reduction in AVNRT duration-frequency in two). The five last patients needed one or more procedures, after which one had no recurrence and one had reduction in duration-frequency. Absence of recurrence after the first procedure was positively correlated with 6-mm-tip cryo-catheter use (<0.001) and negatively with acute procedural success (<0.001). At multivariate analysis, both were independently significant (<0.04 and <0.008, respectively). Long-term clinical success was correlated only with 6-mm-tip cryo-catheter use (<0.001). Slow pathway cryo-ablation is associated with an acute success but a higher recurrence rate. A 6-mm-tip cryo-catheter seems to assure during cryo-ablation a large acute and long-term success. AV-block seems non-guaranteed by a negative cryo-mapping, stressing on need of a careful surveillance. Nevertheless, the theoretical advantage of avoiding the risk of permanent AV-block when compared with radiofrequency needs larger series to be demonstrated.